Influence of a home-based nutrition and exercise program incorporating an app on the quality of life of outpatient palliative cancer patients
Résumé de l'étude
We want to investigate in this study whether a combined exercise and nutrition program with a dietary supplement and a smartphone app has an impact on the personal quality of life of patients. Furthermore, we want to examine whether our therapy program can optimize nutritional status, muscle mass, physical performance, as well as energy and protein intake. Additionally, we would like to study the impact of these measures on fatigue and the clinical course of patients. We are also interested in how well patients adhere to the program and how many patients participate in the study.
(BASEC)
Intervention étudiée
The intervention group receives, in addition to regular medical treatment, nutritional therapy support through dietary counseling and professional, progressive physical training through physiotherapy, which is supported by the intake of a supplemental drink. Additionally, study participants receive an app for their smartphone, allowing them to store data and contact the study team.
(BASEC)
Maladie en cours d'investigation
Patients with tumor disease in the lung or gastrointestinal tract who are not treated curatively.
(BASEC)
- Individuals with a tumor in the lung or gastrointestinal tract who are not treated curatively - Able to engage in physical activity - Able to understand the relevant information and texts for the study (BASEC)
Critères d'exclusion
- Supportive nutritional therapy (enteral nutrition, parenteral nutrition) in the last month - Acute intestinal obstruction in the last month - Allergy to milk protein (BASEC)
Lieu de l’étude
Winterthur, Autre
(BASEC)
Thun
(BASEC)
Sponsor
Kantonsspital Winterthur
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. med. Dr. phil. Christian Britschgi
+41 52 266 36 58
christian.britschgi@clutterksw.chKlinik für med. Onkologie und Hämatologie, Kantonsspital Winterthur
(BASEC)
Informations générales
Kantonsspital Winterthur KSW
(ICTRP)
Informations scientifiques
Kantonsspital Winterthur KSW
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
30.03.2021
(BASEC)
Identifiant de l'essai ICTRP
NCT04859400 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Influence of a home-based nutrition and exercise program including an application for monitoring on quality of life in advanced cancer outpatients (BASEC)
Titre académique
Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients (ICTRP)
Titre public
Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients (ICTRP)
Maladie en cours d'investigation
Cancer, Gastrointestinal;Cancer, Lung;Malnutrition (ICTRP)
Intervention étudiée
Dietary Supplement: Whey protein supplement high in leucine and ?-hydroxy-?-methylbutyrate (HMB);Behavioral: Standardized nutritional program;Behavioral: Standardized exercise program (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Advanced lung or gastrointestinal cancer patients not eligible for curative
treatment
- WHO performance status of = 2
- Able to perform physical exercise estimated by the treating physician
- Estimated life expectancy of = 6 months
- Patient must give written informed consent
Exclusion Criteria:
- Intake of supplements with high-dose branched-chain amino acids within one month
- Enteral (except oral nutritional supplements) and/or parenteral nutrition within one
month
- History of ileus within previous month
- Milk protein allergy
- The patient cannot understand the trial-specific content due to linguistic,
psychological or disease reasons
- Age < 18 years (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
QoL (ICTRP)
Nutritional status;Nutritional status;Nutritional status;Nutritional status;Nutritional status;Nutritional status;Physical function;Physical function;Physical function;Energy- and protein intake;Fatigue;Clinical data;Clinical data;Clinical data;Clinical data;Clinical data;Clinical data;Adherence to the nutritional and exercise program;Usability of the new application;Success of recruitment rate in comparison to former studies (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Krebsforschung Schweiz, Bern, Switzerland;Sponser Sport Food AG;Leitwert GmbH;SNAQ AG;Kantonsspital St. Gallen CTU (ICTRP)
Contacts supplémentaires
Christian Britschgi, PD Dr. med. Dr. phil, Kantonsspital Winterthur KSW (ICTRP)
ID secondaires
2020-02992 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04859400 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible